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AMPOWER: PHASE 3 STUDY DESIGN1

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TRIAL DESIGN

  • Single-arm, open-label trial
  • 112 sites
  • 1384 women aged 18 to 35

 

  • Primary endpoint: 7-cycle cumulative pregnancy rate as calculated by the Kaplan-Meier method
KEY INCLUSION CRITERIA1,a
  • Healthy and sexually active, within the age range of 18 to 35 years old, at risk of pregnancy and desiring contraception
  • Had a normal, cyclic menses with a usual length of 21 to 35 days over the last 2 cycles or at least 2 consecutive spontaneous menses (21-35 days in length) since delivery, abortion, or after discontinuing hormonal contraception or hormonal therapy
  • At low risk for both human immunodeficiency virus (HIV) and sexually transmitted infectionsb
  • At the time of enrollment, had a single male sex partner for ≥3 months
  • Was willing to engage in at least 3 acts of heterosexual vaginal intercourse per cycle
  • Was willing to use the study drug as the only method of contraception over the course of the studyc
  • Willing to report all information in a daily eDiary

aThis is not an exhaustive list of inclusion criteria.

bIn the opinion of the investigator, based on review of high-risk behaviors and exposures according to the Centers for Disease Control and Prevention (CDC) STI Guideline.

cWith the exception of emergency contraception in the event a subject engaged in vaginal intercourse but believed that the study drug was not used properly or she was at risk for pregnancy for any other reason.

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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Few cases (0.36%) of adverse reactions of cystitis, pyelonephritis and other upper urinary tract infection (UTI) have been reported in Phexxi clinical studies. Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of Phexxi in females of reproductive potential with history of recurrent urinary tract infection or urinary tract abnormalities.

ADVERSE REACTIONS

Most common adverse reactions were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.

Patients should be counseled on the following:

  • To contact and consult with their healthcare provider for severe or prolonged genital irritation or experiencing urinary tract symptoms.
  • To discontinue Phexxi if they develop a local hypersensitivity reaction.
  • That Phexxi does not protect against HIV infection or other sexually transmitted infections.

To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1-833-EVFMBIO or you may contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS AND USAGE

Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

LIMITATIONS OF USE

Phexxi is not effective for the prevention of pregnancy when administered after intercourse.

Please see full Prescribing Information for Phexxi.

REFERENCE:

  1. Thomas MA, Chappell BT, Maximos B, Culwell KR, Dart C, Howard B. A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial. Contraception: X. 2020;2:1-6.
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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Few cases (0.36%) of adverse reactions of cystitis, pyelonephritis and other upper urinary tract infection (UTI) have been reported in Phexxi clinical studies. Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of Phexxi in females of reproductive potential with history of recurrent urinary tract infection or urinary tract abnormalities.